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Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

three patients were screened and enrolled in the study.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

Only major consideration for the pre-assignment is to exclude any patient with underlying immunodeficiency or hematological disorder. Investigational product itself can suppress hematopoiesis and is an immuno-modulator.

All three patients screened were enrolled in the study.

Reporting Groups

Description

Sirolimus

There is one arm to the study. All patients will be open-label, Sirolimus. There is no set dosage: medication dose will be based on FDA approved guidelines.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Sirolimus

All patient will be open-label; Sirolimus. Dosage is variable based on FDA guidelines.